PMA P140018S035

Device
VenaSeal™ Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S035
Product code
PJQ
Decision date
2022-11-08
Generic name
Agent, occluding, vascular, permanent
Approval order statement
Updates to the visual inspection criteria for the VenaSeal Adhesive vials.

Current openFDA PMA Record#

Device
VenaSeal™ Closure System
Applicant
Medtronic Vascular, Inc.
PMA number
P140018
Supplement
S035
Product code
PJQ
Generic name
Agent, occluding, vascular, permanent
Decision date
2022-11-08
Decision code
OK30
Date received
2022-10-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Updates to the visual inspection criteria for the VenaSeal Adhesive vials.